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Mebeverine Hydrochloride Tablets IP

Mebeverine Hydrochloride Tablets IP

Composition: Each film-coated tablet contains Mebeverine Hydrochloride IP 135 mg.

Usage: Relief of intestinal spasms and IBS-related abdominal cramps.

Category: Gastrointestinal / Antispasmodic Drugs

Therapeutic category: Musculotropic Antispasmodic

SKU: Mebeverine Tablets

Manufacturer: Healthy Life Pharma Pvt. Ltd.

Exporter: Healthy Inc

Categories: Pharmaceutical Exporter India, Pharmaceutical Formulations India, WHO GMP Certified Formulations

Product Information

Mebeverine Hydrochloride Tablets IP is listed in our pharmaceutical product portfolio for business-to-business enquiries. Product-specific formulation details, available strengths, dosage form, pack configuration and supply terms should be confirmed against the current product specification before ordering.

For distributor, wholesaler, hospital procurement and export enquiries, please request the applicable product specifications, batch documentation, shelf-life information, packaging options and regulatory documents. Availability and documentation depend on the product and destination market.

Description

Mebeverine Tablets (135 mg)

1. Product Introduction

Mebeverine Hydrochloride Tablets IP 135 mg are film-coated, immediate-release antispasmodic tablets used to relieve abdominal cramps and spasms associated with irritable bowel syndrome (IBS) and other functional bowel disorders, where indicated by the approved product label.

Healthy Life Pharma Pvt. Ltd. is listed as manufacturer and Healthy Inc as exporter. Contract manufacturing, certification and export-market availability should be confirmed directly with the supplier.

2. Product Specifications

Product NameMebeverine Hydrochloride Tablets IP
CompositionEach film-coated tablet contains Mebeverine Hydrochloride IP 135 mg
Strength135 mg
Dosage FormFilm-coated tablet (immediate release)
Therapeutic ClassGastrointestinal antispasmodic / musculotropic antispasmodic
UseSymptomatic relief of IBS-related abdominal cramps and intestinal spasms
CAS Number2753-45-9 (mebeverine hydrochloride)
Pharmacopoeial StandardIP, as stated in supplied composition
Packaging and Shelf LifeSubject to approved pack and stability documentation

3. Manufacturing Technology

Manufacturing a consistent 135 mg immediate-release tablet requires validated blending, compression, coating and packaging processes. Film coating can help mask unpleasant taste and support tablet handling. Any particular equipment, excipient system, coating method or extended-release capability must be verified against the actual manufacturing record.

Note: The supplied product is film-coated, not sugar-coated; a separate 200 mg modified-release formulation should not be represented as this product.

4. Quality Assurance

Relevant controls include identification, assay, content uniformity, dissolution, related substances, microbial quality where applicable, and packaging integrity. Acceptance criteria must follow the applicable approved pharmacopoeial monograph and registered specification; specific percentages and test results should not be asserted without a batch certificate of analysis.

5. Pharmacology and Clinical Use

Mebeverine is a direct-acting smooth-muscle antispasmodic used for symptomatic relief of intestinal spasm. It can help with abdominal pain and cramping associated with IBS; it does not cure IBS or treat all causes of abdominal pain. It is not a general analgesic or painkiller and is not primarily an anticholinergic drug.

Persistent or worsening pain, unexplained weight loss, rectal bleeding, fever or new bowel symptoms require medical assessment.

6. Export and Regulatory Support

Product registration, applicable manufacturing authorisations, GMP certificates, certificates of analysis, CTD/ACTD dossiers and export paperwork depend on the destination market and supplier documentation. Contact the manufacturer or exporter to confirm availability and obtain current verified records.

7. Frequently Asked Questions

Q: What is the strength?
A: Each film-coated tablet contains Mebeverine Hydrochloride IP 135 mg.

Q: Is this a painkiller?
A: It is an intestinal antispasmodic used to relieve cramp-related discomfort, not a general-purpose analgesic.

Q: When is it usually taken?
A: Immediate-release 135 mg tablets are commonly prescribed before meals; follow the exact local label and prescriber instructions.

Q: Is this the same as a 200 mg prolonged-release capsule?
A: No. Different strengths and release forms are not automatically interchangeable.

8. Dosage and Administration

For adults, a commonly used regimen for the 135 mg immediate-release formulation is one tablet three times daily, approximately 20 minutes before meals, subject to the approved local prescribing information. Swallow with water. Dosing in children and adolescents depends on local authorisation; do not assume the product is approved for children aged 10 years and above. Seek clinician advice if symptoms persist.

9. Side Effects and Precautions

Allergic reactions, including rash, urticaria and rare angioedema or anaphylaxis, have been reported. Stop use and seek urgent care for swelling of the face or throat, breathing difficulty or a severe allergic reaction. Consult a healthcare professional during pregnancy or breastfeeding, or if there is a history of hypersensitivity. The statement that the medicine is universally safe for long-term use is not supported for every patient.

10. Storage Instructions

Store in the original packaging, protected from excessive heat and moisture, and follow the temperature and shelf-life instructions on the approved product label. Keep out of reach of children.